Pre-procedure meal regimen

ABSTRACT

A colon prep method and kit for facilitating a method for evacuating a colon prior to a medical procedure, wherein the method minimizes potential patient discomfort. Three selected meals and a plurality of selected snacks are ingested on a day prior to the medical procedure. The meals include solid food items taken with or incorporating a stimulant laxative, such as senna, incorporated therein. A liquid having a PEG laxative, such as PEG-3350, is provided with or incorporated therein, preferably via a powdered drink mix. The stimulant laxative and the PEG laxative work in synergy. A further optional snack may be provided on the day of the medical procedure, preferably ingested approximately four hours before the medical procedure.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the priority of U.S. Provisional PatentApplication No. 61/174,452 entitled “PRE-PROCEDURE MEAL REGIMEN,” filedMay 1, 2009, the contents of which are hereby incorporated by reference.

FIELD OF THE INVENTION

The invention relates to a method and kit for facilitating the method ofpreparing a colon for a medical procedure. More particularly, theinvention utilizes a pre-packaged kit having selected food and drinkprovided with, or laced, with laxatives that preclude a patient havingto fast and which facilitates proper colon preparation.

BACKGROUND OF THE INVENTION

The American Cancer Society estimates about 110,000 new cases ofcolorectal cancer will be diagnosed in 2008. Overall, the lifetime riskis 1 in 19. Colorectal cancer is the second leading cause of cancerdeath in the U.S., causing approximately 50,000 deaths estimated for2008. The death rate, however, has been dropping for more than 20 yearsdue to polyp detection. Colonoscopy is the gold standard in diagnosingand removing precancerous polyps, thereby preventing colon cancer. Ratesfor screening have perennially been poor, partially related toavailability of proceduralists, referral patterns of physicians, butalso largely due to patient reluctance.

Colonoscopies have traditionally had a poor name due to cost, discomfortand most importantly, the prep. The cost has steadily declined withcoverage by Medicare and insurance companies. Discomfort has also beenaddressed with IV anesthetics and the use of Propofol. Colonoscopypreps, however, have not made significant advances in over 40 years.

Adequate colon exams require adequate visualization of the colonicmucosa. Bowel preparations are evaluated on three criteria: efficacy incleansing, safety, and tolerability. Unfortunately no preparation todayis the clear winner in all three categories.

Laxative Types

There are three types of bowel purgatives for colonoscopy: stimulants,osmotic agents, and polyethylene glycol based solutions (PEG).Stimulants include senna, cascara, bisacodyl, and sodium picosulfate.Osmotic preps include sodium phosphate (NaP, a hypertonic saltsolution), magnesium citrate and mannitol. Osmotic agents andnon-absorbable large volume lavages (PEG) taken with “clear liquiddiets” have been the standard for colon preparations for years. Theyare, however, associated with a multitude of complaints includingbloating, cramping, nausea, vomiting, bad taste, hunger, weakness, andthe inability to understand prep directions. These complaints representan important barrier to compliance with colonoscopy. Suboptimal bowelpreparation leads to prolonged procedure times, lower rates of cecalintubation, reduced screening intervals, higher screening costs andpossibly increased risk for procedural complications. Inadequatecleansing of the colon, reported to occur in approximately 27% of allexams, results in missed adenomas as reported by Froehlich F., inGastrointestinal Endoscopy 2005, Volume 61, Pages 378-384. Also 17-30%of suboptimal colonoscopies in different trials were because ofinadequate bowel preparation.

1. Fiber. Much of the prior art, with respect to bowel movements dealswith ingestible fiber or bulking agents in the form of psyllium,methylcellulose, polycarbophil, calcium polycarbophil, bran, malt,pectin, soup extract, karaya guar gum and various mixtures. Thesecomponents cause a change in the composition and fluid content of stoolbut do not cause a cathartic effect with total evacuation of coloncontents. In fact, one of their benefits is minimal to no diarrhea. Theyare also much slower in onset of bowel changes. Stool softeners offer anintermediate between bulk and stimulant laxatives. Dioctylsulfosuccinate is the active ingredient in some. It is an anionicmedicinal surfactant possibly acting as an intestinal secretogogue andenhancing retention of luminal fluid increasing fecal fluid content.This, again, is typically used in the occasional treatment ofconstipation but not as a diarrheagenic producing agent.

2. Senna. Stimulants include cascara and senna. Senna is a plant-derivedcompound from the leaves, or pods, of various species of the cassiaplant. Commercial sources include the species cassia angustifolia(Tinnevella senna) and cassia acutifolia (cassia senna or Alexandriasenna). Commercial concentrates range from 20-95% calcium sennosides.The senna plants are small shrubs cultivated either in Somalia, theArabian Peninsula or near the Nile River. Tinnevella senna is obtainedfrom cultivated plants mainly in south India and Pakistan. The activeingredient of senna was first isolated and characterized by Stoll in1941. There are two glycosides identified and attributed to theanthraquinone family senusoids A and B. They both hydrolyze to give theaglycones sennidin A and B and two molecules of glucose. Later work alsodemonstrated the presence of senusoids C and D. Studies have shown thatthe anthraquinone glycosides pass unchanged into the colon wherebacteria hydrolyzed the glycoside bond, yielding 3 anthraquinones whichhas a direct stimulant effect on the myenteric plexus of the bowel,resulting in smooth muscle contraction and, thus, defecation. It alsohelps to temporarily prevent fluid from being absorbed by the largeintestine, thus contributing to softer stools. Senna has been used bypeople in northern Africa and southwestern Asia as a natural laxativefor centuries. It was labeled a “cleansing” herb for its laxativeeffects. The leaves were also sometimes made into a paste and used forvarious skin conditions. Senna is considered a sage and effectivelaxative used throughout the world. It is currently sold commercially asan active ingredient in laxative products or as a sale OTC laxative torelieve occasional constipation. Senna has not however been typicallyused as an agent to prepare patients for endoscopic, radiologic orsurgical procedures.

K. Butt and colleagues conducted a randomized blinded study to comparethe efficacy and patient tolerance of high dose oral senna suspensionversus a conventional sodium phosphate prep in adults undergoingelective colonoscopy. Patients either received two doses of liquid senna(158 mg each, 8 hours apart) the day before colonoscopy (N=50) or aconventional sodium phosphate regimen (48 grams; N=50). Tolerance andcompliance was significantly better with the senna preparation than withthe sodium phosphate with more patients reporting good tolerance (46versus 28 patients) and fewer reporting poor tolerance (0 versus 12patients) to the senna versus the sodium phosphate regimen. Also therewas a trend toward improved preparation quality.

Another study by F. Radaelli and colleagues was published in theAmerican Journal of Gastroenterology in December 2005 comparing oralhigh dose senna to standard 4 liter PEG solution. 191 patients wererandomized to the senna group (24 tablets of 12 mg senna divided into 2doses at 1:00 P.M. and 9:00 P.M.) versus 192 patients who received thestandard 4 liter PEG preparation. Regardless of which prep was used, allpatients were instructed to eat a low fiber diet and increase waterintake on the 4th through 2nd pre-procedural days. On the day before theprocedure, they were advised to eat a normal breakfast in the morningand clear liquids thereafter until 2 hours before the colonoscopy. Thequality of colon cleansing, overall tolerance of the preparation andcompliance were significantly better with senna. Radaelli preppedpatients with 288 mg total senna in two divided doses with good coloncleansing but increased abdominal pain compared with 4 liters PEG.

3. Sodium Phosphate. Hypertonic salt solutions have been used for manyyears and, in fact, the first Fleet laxative was developed in 1893 byDr. C. B. Fleet. Fleet's phosphosoda is a hypertonic saline catharticagent that pulls water into the bowel lumen to flush the food residuefrom the GI tract. This influx of fluid into the bowel causes boweldistention and contractions of smooth muscle in the bowel wall. Thepatient may experience bloating and cramping with resultant diarrhea. Italso can cause nausea and vomiting because of the salty taste and bowelcontractions. More importantly, the preparation frequently causeselectrolyte shifts and potentially dangerous electrolyte imbalances. Inaddition to electrolyte shifts, cases of an acute phosphate nephropathyhave been reported causing permanent kidney damage. Calcium phosphatemay form in the kidney, damaging nephrons and the structure of thekidney, possibly leading to renal failure. This has prompted a warningby the FDA in May 2006.

4. Polyethylene Glycol. Whole bowel irrigation was originally developedto cleanse the large bowel before surgery or colonoscopy. The initialelectrolyte solution was partially absorbed, sometimes leading tocomplications. Then, a specialized isoosmolar solution calledpolyethylene glycol (PEG) was developed to combat this problem. PEG is apolyether with a molecular mass below 20,000 grams per mol. Polyethyleneglycol has a low toxicity and is used in a variety of products. It isavailable in liquid and powder form and is the basis of a number oflaxatives, skin creams and lubricants among other commercial products.PEG with added electrolytes is sold under the brand names Go-Lightly,MiraLax®, GlycoLax®, Tri-Lite, Co-Lyte and Half Lightly®. MiraLax® has amolecular weight of 3,350. PEG solutions have been used on millions ofpatients preparing for colonoscopic procedures. These preparationsinvolve ingestion of 2-4 liters of solution with resultant diarrhea.Unfortunately ingestion of PEG is also generally accompanied by a senseof fullness, cramping, nausea, and vomiting. Patients frequently havedifficulty completing the prep, thereby causing inadequate bowelcleansing.

Recently, the use of a powdered PEG-3350, or MiraLax® has been reportedas a sole bowel preparation agent. MiraLax® was initially introduced asa prescription agent for the treatment of occasional constipation. After10 years on the market, it was produced as a generic called GlycoLax®until an FDA arrangement for a 3-year marketing exclusivity agreement asOTC MiraLax® which expires in approximately the winter of 2009.

In a study by M. Arora, published in Gastroenterology and Hepatology,July 2008, 245 patients were studied who received 204 grams of powderedPEG-3350 dissolved in 32 ounces of water and taken in 3 divided doses,one hour apart with 8 ounces of water in between each dose. The colonpreparations were then compared to patients receiving a standard sodiumphosphate prep. A scale of 0-4 was used for colon preparation with thezero being a failed procedure due to a poor prep and 4 being completelyclean. The MiraLax® group was calculated to have a mean score of 3.43and therefore, quite favorable as a bowel preparation agent.

Prep Barriers

One-third (34%) of patients reported mid-range to severe discomfort fromthe preparation regimen to clear the bowel in an A.A.A.H.C. reportsurveying 2,000 people at 107 ambulatory surgery centers from August toNovember of 2007. The prep was their number one complaint. Thecombination of numerous gastrointestinal upsets, including taste,nausea, vomiting, bloating, and cramping associated with these agentsleads to an almost universal avoidance by patients of a potentiallylifesaving procedure. Patients frequently have difficulty completing thepreparation but are unable to quantify their colon cleanliness. Theymiss work, with its associated costs, and undergo attempted colonoscopywhich may be incomplete with regard to inspection of the full colon dueto a poor colon cleanse. Studies have shown significant expense relatedto poor prep due to repeat exams or shorter surveillance intervalsbecause of decreased confidence by the endoscopist in their colonoscopyfindings.

Annual demand for colonoscopy ranges from 8-14 million and isincreasing. Studies demonstrate a severe undersupply of professionalsable to perform endoscopies, including gastroenterologists, surgeons,primary care physicians and physician extenders. This has beenassociated with a higher volume of screening colonoscopies perphysician, and in some cases, a decrease in the pre-procedureinstruction time spent with patients.

In a study published in the American Journal of Gastroenterology in June2001, researchers studied pre-endoscopy education. The study included142 patients. Cancellation of the procedure occurred in 26.3% ofpatients in a written instruction group versus 4.4% in a more rigorouspatient education group.

In addition to inadequate pre-procedure teaching, low literacy isanother cause of poor bowel preparations. In a study of 195 patients atan inner city hospital presented at “Digestive Disease Week” in 2006,30% had poor bowel preparation, requiring a repeat exam. Another 22% hadonly “fair” bowel preparation, meaning small or flat lesions could bemissed. A 7-minute literacy test determined 40% had low literacy and 20%marginal literacy. Those with the low literacy had a 63% rate of poorbowel preps compared with 12% of those patients with marginal oradequate literacy. The researchers concluded that better methods ofexplaining colonoscopy preparation must be developed.

Prep Diets

Traditionally, patients have also been placed on long periods of clearliquids while they are enduring a colon preparatory agent to ensureadequate bowel cleanliness. This “diet” first requires they understandthe meaning of a clear liquid diet. While that may be obvious to some,many patients have great difficulty discerning different food productsas “clear liquids”. They must then purchase and prepare clear liquidsthat are not a typical part of their natural dietary regimens. Lastly,the patient must have the willpower to fast despite increased hungerassociated with ingestion of only clear liquids. S. McCray, R. D. and D.Balaban, M. D. summarized a series of studies in PracticalGastroenterology in November 2007 that looked into these diet regimensthat may be more tolerable to patients but still produce adequate colonpreparation when combined with current bowel laxatives.

Scott, et al, randomized 200 patients undergoing colonoscopy to receivea sodium phosphate oral preparation with either: 1) standard lightbreakfast followed by clear liquids on the day before the colonoscopy,or 2) normal breakfast, low residue lunch, and then clear liquidsthrough the remainder of the day prior to the exam. There were nosignificant differences with either diet with 93-95% reported as good toexcellent preparation. However, the subjects consuming the low residuelunch reported less hunger and more energy, therefore permitting them toperform their usual daily activities.

Delegge randomized 506 colonoscopy patients to receive either: 1) clearliquid diet and sodium phosphate prep, or 2) NeutraPrep, a low residuemeal kit with magnesium citrate colon preparation. Both preparationsresulted in greater than 80% good or excellent colon cleansing with aslight increase, 85% versus 73%, in subjects that would repeat thispreparation for a future exam.

Rapier, et al, studied 114 patients to receive either: 1) clear liquiddiet and a laxative kit with mag citrate oral bisacodyl tablets and abisacodyl suppository; 2) the low residue meal kit with the abovelaxative kit; or 3) the low residue meal kit with PEG solution. 81% ofgroup 1, 89% of group 2, and 92% of group 3 had a good or excellentcolon cleansing rating by the endoscopist. Despite showing the use oflow residue diet as safe and effective, however, there were nosignificant differences in how the patients rated the tolerability ofthe regimen in this study.

Aoun, et al, took this one step further and evaluated the effectivenessof an unrestricted diet on the day before colonoscopy. 141 patients wererandomized to: 1) 4 liter PEG and clear liquid diet the day before theprocedure, or 2) 2 liter PEG and regular diet (up until 6:30 P.M. theday before the procedure) and 2 liter PEG on the morning of theprocedure. The clear liquid group had 56.2% good to excellentpreparation compared to 76.5% in the regular diet group. The regulardiet group also demonstrated a non-significant trend towards increasedcompliance (90% versus 78%).

Another significant and well described problem is the movement of ilealchyme into the cecum and right colon if the last laxative is ingestedgreater than 6 hours before the procedure time. This chyme effluent isvery adherent to the colonic mucosa and difficult to irrigate orsuction, making visualization of the right colon suboptimal. Splitdosing of the laxatives (sodium phosphate and PEG) by giving the seconddose of laxative approximately 4 hours before the procedure, has beenshown to provide clearing of this ileal effluent and improved rightcolon viewing with colonoscopy. Unfortunately, patients scheduled formorning procedures would be required to awaken at 3:00 A.M. and later toingest another dose of unpleasant laxative. They would then redevelopdiarrhea with its associated symptoms throughout the morning hours, withfurther loss of sleep, GI distress and the practical problem of tryingto travel to the endoscopy suite with lingering GI symptoms and possibleincontinence. It is the practice of some institutions and endoscopiststo routinely give split dose prep instructions of either sodiumphosphate or PEG, to optimize bowel preparation. A large number ofpatients, however, are still given same day prep directions to preparetheir colon on the day before their procedure to minimize the alreadyunpleasant and cumbersome task of tolerating colon preparation.

Patents and Patent Publications

Review of the prior art reveals a number of patents concerned with bowelhealth and bowel preparations. Most of these bowel preparations havebeen discussed above. Two such patents, U.S. Pat. No. 6,866,873, andU.S. Pat. No. 7,282,223, describe a nutritional dietary system,formulation, kit and method for use in preparing an individual for apredetermined activity.

In reviewing the past studies, and from clinical experience withapproximately 15,000 to 17,000 colonoscopy patients, the importance, yetdifficulties of colonoscopy preparation are well documented. Thus, atypical statement heard from patients is, “the prep was way worse thanthe procedure”. Therefore, a method and kit that facilitates good colonprep with minimal patient disruption is desirable.

SUMMARY OF THE INVENTION

A colon prep method and kit for facilitating the method for evacuating acolon for a medical procedure, such as a colonoscopy, wherein the methodminimizes potential patient discomfort. The method includes the steps ofingesting three selected meals and a plurality of selected snacks on aday prior to the medical procedure. The meals include solid food itemsthat are provided with a stimulant laxative or that have a stimulantlaxative incorporated therein. The stimulant laxative is preferablysenna. Additionally, the meals include a liquid having a PEG laxativeincorporated therein. The PEG laxative is preferably PEG-3350. In thekit of the invention, a powdered drink mix is preferably provided. Thestimulant laxative and the PEG laxative work in synergy.

A further optional snack may be provided on the day of the medicalprocedure. The same day snack includes a solid food item provided with astimulant laxative or that have a stimulant laxative incorporatedtherein. The same day snack additionally includes a liquid having a PEGlaxative incorporated therein. Preferably, the same day snack isingested approximately four hours before the medical procedure.

In a preferred method, the three selected meals include a meal packagecontaining approximately 70 mg of senna and a drink mix containingapproximately 68 gm of PEG-3350. The senna in the meal package may beprovided with a solid food item or may be incorporated into a solid fooditem such as a muffin, oatmeal, pasta with sauce, beef or chicken basedsoup with crackers.

The PEG-3350 in the drink mix is preferably incorporated into a drinkitem such as a cran-apple drink mix, lemonade drink mix. The snackpackage preferably contains approximately 26-36 mg of senna and thedrink mix of the snack package preferably contains approximately 68 gmof PEG-3350. The senna in the snack package is preferably incorporatedinto a food item such as chocolate pudding, a chocolate bar, or achocolate Rice Krispies treat.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic diagram of the kit of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In light of the shortcomings associated with known preps and dietregimens, the kit and method of the invention provides a simplesolution. Safe laxative ingredients are provided with food and drinks ormay be placed into food and drinks in a stepped residue diet kit thatoffers simplicity, good taste, affordability, and effective bowelcleansing. In one embodiment, senna, which does have a bitter taste, isprepared in solid foods to produce stimulation of gut motility. PowderedPEG-3350 is dispersed in fluids to produce an osmotic lavage of thebowel contents. These two agents work in concert with each other toproduce bowel cleansing. While the idea of mixing medicine with ateaspoon of sugar is an old concept, the kit of the invention uses aspecific type of food and drink combination with specific carbohydrate,protein and fat mixtures, fiber content, preparation temperatures,color, and textures with appropriate laxative doses.

Senna has a bitter taste and brownish color and, therefore, may beprepared with foods of specific corresponding color, acidity, taste, andtexture to disguise both of these unpleasant characteristics. Senna alsoundergoes degradation above certain preparation temperatures, requiringlower temp/quicker preparation type foods.

The laxative dosage must also be specific and graded to provide aminimal needed amount to produce adequate laxative effect versus asupra-therapeutic amount that tends to produce abdominal cramps andpain. The stimulation of senna, either administered with or incorporatedinto solid foods will work in synergy with the osmotic laxative effectof PEG-3350 in the fluids ingested allowing a smaller effective dose ofboth agents.

The preparation of the invention involves frequent small doses of senna,either administered with food products or hidden in the food products,i.e., doses of 0-64 mg in the main meals, alternating with 0-34 mg ofsenna administered in or with snacks to be every 2-3 hours, again in theform of breakfast, lunch, dinner and snacks with a total dose of 108 mg.In greater detail, 0-125 mg of senna, as part of the inventive regimen,is believed to be effective for meal dosing with 12.5-64 mg senna beingpreferred and 37.5 mg senna being more preferred.

The timing of meals, snacks and drinks is also of considerableimportance due to the requirement of contact with colonic bacteria todegrade senna to its active form. This delay from oral ingestion toeffect will be of longer duration after the first meal (3-5 hours) thanthe last meal (0.5 to 1 hour) because of increased bowel motility assubsequent laxatives are ingested. The bulk of stooling and preparationof the colon should be completed by 9 to 10 o'clock of the night beforeprocedure.

PEG-3350 powder (MiraLax®, GlycoLax®) is a powder that, when mixed withliquid, becomes tasteless, odorless, colorless and clear. It does alterthe composition of solid foods, however, and therefore is restricted inthe kit of the invention to liquid drink mixes. PEG-3350 produces anosmotic laxative effect by retention and excretion of fluid into thebowel with associated bowel distention, contractions and subsequentdefecation. PEG-3350 can be associated with abdominal fullness andbloating due to its physiologic action. As noted before, however, itwill work synergistically with senna, allowing our use of lower doses.In the prep of the invention, 17-34 grams of PEG-3350 are mixed perdrink for a total of 136 to 153 grams. In greater detail, 0-102 g ofPEG-3350, as part of the inventive regimen, is believed to be effectivefor meal dosing with 17-68 g being preferred and 34 g being mostpreferred.

Having the option of a split dose laxative within the kit of theinvention also provides a unique element over other bowel preparations,namely the ability to individualize the preparation to the patient'stypical bowel habits. All previous bowel preparations follow a similaryet flawed assumption, one size fits all. There are typically noprovisions for the variety of bowel habits that are seen in a patientpopulation. Therefore, for example, four liters of Golytely may be toolittle for some patients and too much for the next patient, and so onfor all of the currently available bowel preparations. In addition tothe physical discomfort of too much preparation with its associatedcramps, nausea, bloating, diarrhea, and perirectal pain, patientsexperience emotional distress over presenting for an embarrassing examwith a not fully clean colon. The greater risk actually lies in theinability to adequately visualize a poorly prepped colon, thereforeincreasing the patient's risk that polyps and other lesions may bemissed. Lastly, studies have shown that poor preps lead to shorterrecommended screening intervals, more procedures, and greater healthcarecosts.

The inventive kit includes a time appropriate snack with a drink lacedwith senna and PEG-3350, respectively, or taken with senna and PEG-3350,to be given 4 hours before the procedure depending on the endoscopist'spreference, patient's bowel history (e.g., history of chronicconstipation) and whether the patient senses incomplete bowel evacuationwith the previous day's diet and prep (e.g., abdominal rectal fullnessor cloudy stool effluent on the morning of the exam). Patients scheduledfor afternoon cases could also use the snack and drink 4 hours beforethe afternoon times with no undue discomfort of awakening in earlymorning hours.

Both senna and MiraLax® (PEG-3350), appear to be very safe with numerousreports showing no significant changes in electrolytes, EKG's orclinical symptoms. This is opposed to frequent electrolyte alterationsand infrequent, but extremely dangerous, hyperphosphatemia with renaldamage associated with sodium phosphate colon preparations. This haslead to Fleets phosphosoda being removed from the OTC shelves in 2008and now being available by prescription only. Fleets phosphosoda and theother current prescription phosphosoda tablets now carry a blackboxwarning concerning the risk of kidney damage. This will likelysignificantly reduce their use as bowel preparation agents furtherlimiting patient's choices of safe bowel preparation agents. The otherfactors that are more difficult to estimate but documented to bebarriers to colonoscopy including the cost of some laxatives (HalfLightly can cost in the range of $60-$80), the difficulty ofunderstanding a “clear liquid diet” instruction sheet, difficulty inpreparing a clear liquid diet, and possibly most important, thewillpower to “just have liquids” or “fast” for 24-36 hours before theprocedure.

Referring now to FIG. 1, the inventive diet preparation kit costsapproximately $25-$35, requires no understanding of clear liquid diets,is packaged to simplify preparation of meals and drinks so that mealsneed only to be mixed with water or heated less than 90 seconds in amicrowave and don't require “fasting or not eating”. In a preferredembodiment, the kit is packaged in a single box 10 with a carryinghandle. Within box 10 is a package 12 labeled #1 for breakfast, apackage 14 labeled #2 for lunch, and a package 16 labeled #3 for dinner.Three snacks 18, 20, 22 are provided that are associated with breakfast,lunch and dinner. The snacks 18, 20, 22 are labeled as morning snack,afternoon snack and evening snack. Additionally, an optional snackpackage 24, containing a food and drink mix are provided for ingesting 4hours before the procedure.

Package 12, containing breakfast kit #1 preferably includes typicalbreakfast foods 26 and drink mixes 28. Package 12 may include, but isnot limited to, a blueberry muffin with 0-36 mg of senna, an oatmealpackage with 0-36 mg of senna and a cran-apple drink mix for mixing with12 ounces of water. The drink mix 28 preferably has 0-68 gram ofPEG-3350. Package 18, containing a morning snack is preferably a solidfood item 30, such as typical snack food. Package 18 may include, but isnot limited to, chocolate pudding with 0-36 mg of senna. Package 18preferably contains a drink mix 32 containing PEG-3350

Package 14, containing the lunch kit, preferably includes typical lunchfoods. Package 14 preferably includes, but is not limited to, food item34, such as a pasta with sauce having 0-36 mg of senna, and drink mix36, such as a lemonade drink mix with 0-68 grams of PEG-3350. Package20, containing the afternoon snack preferably contains a solid food item38, such as a typical snack food. Package 20 preferably includes, but isnot limited to, a chocolate bar with 0-36 mg of senna.

Package 16, i.e., the dinner kit, preferably includes solid food items42, such as typical dinner foods. Package 16 preferably includes, but isnot limited to, a beef or chicken based soup with crackers, 0-36 mg ofsenna in the soup, and a drink mix 44 with 0-68 grams of PEG-3350. Everysnack package 22 preferably contains solid food item 46 and a drink mixitem 48.

Package 24, containing an optional snack used for split dose prepping,preferably includes a solid food item 50, such as a typical snack food.The snack is preferably, but is not limited to, a chocolate RiceKrispies® treat with 0-36 mg senna and a drink mix 52 with 0-68 grams ofPEG-3350. All meals and snacks are preferably packaged in one box with acarrying handle and prep directions on the inside and outside of thebox.

The present invention is a significant advance over the prior art, bypermitting the patient to be on a much more liberal diet on the daybefore a procedure than is typically permitted. This should markedlylessen patients discomfort associated with clear liquid and low residuediets. The method and kit of the invention requires essentially nowillpower, the lack of which interferes with many patients' colonpreparations.

Secondly, and probably of much more importance, the method and kit ofthe invention address the worst part of colon preparation, the prepitself. By using foods and drinks with specific tastes, colors,textures, acidity, quantities and preparation qualities, a stimulant andlow volume PEG agent can be taken separately or incorporated directlyinto food and drink in a manner which preserves food and drinkpalatability. Furthermore, by using a specific quantity and combinationof stimulant and PEG agent at specific times, less quantity of eachlaxative is needed, markedly lessening the discomfort typicallyassociated with a laxative when used as single agents to prepare thecolon.

Clinical Observations

Support for the concept of the invention includes experience resultingfrom some 19 years of didactic training, literature review and clinicalexperience of the inventor. Historically, patients are placed on a clearliquid diet for 24-48 hours prior to their colonoscopy while theysimultaneously ingest their colon prep. In the course of performing over20,000 colonoscopies, many patients have presented with GI symptomsnecessitating colonoscopy on the following day. Patients have typicallybeen on a regular diet for breakfast and lunch prior to beginning theircolon prep. The prep would then commence in the afternoon or eveningprior to their procedure the next day. Despite this non-adherence to aclear liquid diet for the entire day of colon preparation, they presentfor colonoscopy usually with very satisfactory colon cleansing. It isclear that a more liberal diet on the prep day can still allow anadequate preparation of the colon.

In addition to multiple anecdotal cases, observational studies wereperformed with portions or an entire meal plan in accordance with theinvention. A stepped phase approach to trials of various meals beginningwith a single meal/laxative along with a drink mix/PEG3350 laxative wereconducted, progressing to a complete prep process that included:breakfast, lunch, dinner, snacks and drinks with laxatives. Participantswere asked which of the following most accurately described their mostpredominate bowel pattern prior to beginning the prep: constipated (lessthan 1 bowel movement every 3 days), normal (from 1 bowel movement every3 days to 3 bowel movements per day), and frequent (more than 3 bowelmovements per day).

Participants were given instructions on how to prepare the meals anddrink mixes. Each meal and drink were consumed together at one sitting.Comments were then recorded as to the ease of preparation using a ratingof 1 to 4 selected from the following: easy to prepare (score 1),moderate difficulty to prepare (score 2), and very difficult to prepare(score 3). Palatability of the meal and drink were each rated from 1 to3: good taste (score 1), fair taste (score 2), and bad taste (score 3).

A stool diary was kept that described the number and consistency ofbowel movements (hard, formed, soft, loose or watery) followingingestion of the prep. The presence of side effects (abdominal pain,gas, bloating, nausea and vomiting) was rated on a scale from 1 to 4:absent (score 1), mild (score 2), moderate (score 3) and severe (score4).

Experimental Results:

Participant #1—received breakfast meal kit containing dry oats flavoredwith butter buds, cinnamon, and Splenda®, mixed with 25 mg of senna, inaddition to a dry cran-apple powdered drink mixed with 54 gm ofMiralax®. The participant was given instructions to mix the dry oatswith one cup of water and heat with the microwave on high for 90seconds. The powdered drink was to be mixed with 16 oz of water for oneminute.

Participant #1 rated the food and drink mix both 1 for ease ofpreparation, both 1 for taste, and 1 for side effects. Stools beganwithin 1 hour of finishing the meal and drink. Initially the stool wasformed and then progressed to loose but not watery for a total of 5bowel movements. Participant #1 reported normal pre-prep bowel habits.

Participant #2—received a lunch meal kit containing an Italian stylepasta bake with 25 mg of senna and a lemonade powdered drink with 34grams of PEG 3350 mixed with 16 oz of water. The pasta bake was heatedfor 90 seconds in a conventional microwave.

Participant #2 rated the food and drink mix both 1 for ease ofpreparation, both 1 for taste, and 2 for side effects. Side effects weredescribed as some mild gas 6 hours after the prep. No bloating orcramping were noted. Stools began 2 hours after finishing the meal anddrink. Two bowel movements were produced and were both formed.Participant #2 reported normal pre-prep bowel habits.

Participant #3—received a lunch meal kit containing the same ingredientsas participant #2.

Participant #3 rated the food and drink mix both 1 for ease ofpreparation, both 1 for taste, and 2 for side effects. Side effects weredescribed as gas 5-6 hours after the prep. Two bowel movements wereproduced and were both formed. Participant reported constipated pre-prepbowel habits.

Participant #4—received a breakfast meal kit and a lunch meal kit. Thebreakfast kit included the dry oats with seasonings and 25 mg of senna.A powdered orange drink was mixed with 51 gm of PEG 3350 with 16 oz ofwater. The lunch kit included spaghetti with meat sauce and 37.5 mg ofsenna along with a lemonade drink mixed with 51 gm of PEG 3350 and 16 ozof water. Preparation instructions were given.

Participant #4 rated the food and drink mixes for breakfast and lunch asboth 1 for ease of preparation, both 1 for taste, and 2 for sideeffects. Side effects were described as some mild upper abdominal painand gas beginning 5.5 hours after the lunch meal. Bowel movements began8 hours after the lunch meal and initially were hard and progressed toloose by the next morning (22 hours later), approximately 6-8 bowelmovements in total. Participant reported constipated pre-prep bowelhabits.

Participant #5—received a dinner kit containing spaghetti with meatsauce and 37.5 mg of senna along with a powdered cranberry drink mixedwith 34 gm of PEG 3350 and 16 oz of water. Preparation instructions weregiven.

Participant #5 rated the food and drink mix both as 1 for ease ofpreparation, both 1 for taste, and 1 for side effects. Bowel movementsbegan 2 hours after the dinner was ingested and were hard initially andprogressed to formed, 2 bowel movements total. Participant reportedconstipated pre-prep bowel habits.

Participant #6—received a breakfast kit containing flavored oats and 25mg of senna with toast, along with a powdered orange drink mixed with 34gm of PEG 3350 and 16 oz of water. The participant received a lunch kitcontaining a soup consisting of meat, potato and bean with crackersalong with a powdered raspberry drink mixed with 34 gm of PEG 3350 and16 oz of water. The participant received a dinner kit containingspaghetti and 37.5 mg of senna along with a powdered lemonade drinkmixed with 34 gm of PEG 3350 and 16 oz of water. Participant received amid-morning snack consisting of chocolate pudding and a mid-afternoonsnack consisting of a chocolate Rice Krispies® bar, each with 25 mg ofsenna. The participant was allowed additional fluids as desired andinstructions were given for the meal kits and snacks.

Participant #6 rated all of the food and drink mixes as 1 for ease ofpreparation, 1 for taste, and 1 for side effects. Both snacks were ratedas 2 for taste. Bowel movements began 3.25 hours after the first mealkit with formed stool and progressed to loose stool. A total of 14stools were reported during and immediately after the prep period.Participant reported normal pre-prep bowel habits.

Participant #7—received the same meal kits and snacks as participant #6.The participant was allowed additional fluids as desired andinstructions were given for the meal kits and snacks.

Participant #7 rated all of the food and drink mixes as 1 for ease ofpreparation. Participant rated breakfast, mid-morning snack and lunchmeals a 2; mid-afternoon snack and dinner meal a 1 for taste. Sideeffects were rated at 1. Bowel movements began 8.5 hours after the firstmeal kit with loose stool and progressed to watery. Participant reportedmultiple bowel movements. Participant reported constipated pre-prepbowel habits.

Participant #7 underwent colonoscopy on the following morning. Theprocedure was carried out using standard protocol with IV conscioussedation (midazolam and meperidine) by an unblinded board certifiedendoscopist. Total procedure time and ileocecal intubation wererecorded. Global colon cleansing was rated using an Aron-chick scoringscale (1-excellent, 2-good, 3-fair, and 4-inadequate). Colon cleansingwas rated as a 1 by the unblinded endoscopist.

Thus, the present invention is well adapted to carry out the objectivesand attain the ends and advantages mentioned above as well as thoseinherent therein. While presently preferred embodiments have beendescribed for purposes of this disclosure, numerous changes andmodifications will be apparent to those of ordinary skill in the art.Such changes and modifications are encompassed within the spirit of thisinvention as defined by the claims.

1. A colon prep method for evacuating a colon for a medical procedurewherein the method minimizes potential patient discomfort, the methodcomprising the steps of: ingesting three selected meals and a pluralityof selected snacks on a day prior to the medical procedure; wherein saidmeals comprise a solid food item having a stimulant laxative providedtherewith; wherein said meals comprise a liquid having a PEG laxativeprovided therewith.
 2. The method of claim 1 wherein: said stimulantlaxative is incorporated in said solid food item.
 3. The method of claim1 wherein: said PEG laxative is incorporated in said liquid.
 4. Themethod of claim 1 further comprising the steps of: ingesting a snack onthe day of the procedure; wherein said snack comprises a solid food itemhaving a stimulant laxative provided therewith; wherein said snackcomprises a liquid having a PEG laxative provided therewith.
 5. Themethod of claim 4 wherein: said stimulant laxative is incorporated insaid solid food item.
 6. The method of claim 4 wherein: said PEGlaxative is incorporated in said liquid.
 7. The method of claim 1wherein said solid food item, said liquid, said stimulant laxative andsaid PEG laxative are ingested approximately four hours before themedical procedure.
 8. The method of claim 1 wherein said stimulantlaxative of said meals is comprised of senna.
 9. The method of claim 1wherein said PEG laxative of said meals is PEG
 3350. 10. The method ofclaim 4 wherein said stimulant laxative of said snack is comprised ofsenna.
 11. The method of claim 4 wherein said PEG laxative is PEG-3350.12. The method according to claim 1 wherein: said stimulant laxative andsaid PEG laxative work in synergy.
 13. The method according to claim 1wherein said three selected meals comprise: a meal package comprisingapproximately 70 mg of senna; a drink mix comprising approximately 68 gmof PEG-3350.
 14. The method according to claim 1 wherein said threeselected meals comprise: a meal package comprising approximately 125 mgof senna; a drink mix comprising approximately 102 gm of PEG-3350. 15.The method according to claim 1 wherein said three selected mealscomprise: a meal package comprising approximately 12.5-64 mg of senna; adrink mix comprising approximately 17-68 gm of PEG-3350.
 16. The methodaccording to claim 1 wherein said three selected meals comprise: a mealpackage comprising approximately 0-64 mg of senna; a drink mixcomprising approximately 17-34 gm of PEG-3350.
 17. The method accordingto claim 1 wherein said three selected meals comprise: a meal packagecomprising senna; wherein the senna in the meal package is incorporatedinto a solid food item selected from the group consisting of: muffin,oatmeal, pasta with sauce, beef or chicken based soup with crackers. 18.The method according to claim 1 wherein said three selected mealscomprise: a drink mix comprising PEG-3350; wherein the PEG-3350 in thedrink mix is incorporated into a drink item selected from the groupconsisting of: cran-apple drink mix, lemonade drink mix.
 19. The methodaccording to claim 1 wherein said plurality of selected snacks comprise:a snack package containing approximately 26-36 mg of senna; a drink mixcomprising approximately 68 gm of PEG-3350.
 20. The method according toclaim 1 wherein said plurality of selected snacks comprise a snackpackage wherein the senna in the snack package is incorporated into afood item selected from the group consisting of: chocolate pudding,chocolate bar, chocolate Rice Krispies treat.
 21. A colon prep kit forfacilitating evacuating a colon for a medical procedure, said kitcomprising: three pre-packaged meals; wherein said pre-packaged mealsare comprised of a solid food item and a stimulant laxative providedtherewith; wherein said pre-packaged meals are comprised of a drink mixand a PEG laxative provided therewith.
 22. The kit according to claim 21wherein: said stimulant laxative is incorporated in said solid fooditem.
 23. The kit according to claim 21 wherein: said PEG laxative isincorporated in said drink mix.
 24. The kit of claim 21 wherein saidstimulant laxative is comprised of senna.
 25. The kit of claim 21wherein said PEG laxative is PEG-3350.
 26. The kit of claim 21 furthercomprising: a plurality of pre-packaged snacks; wherein saidpre-packaged snacks are comprised of a solid food item and a stimulantlaxative provided therewith; and wherein said pre-packaged snacks arecomprised of a drink mix and a PEG laxative provided therewith.
 27. Thekit according to claim 26 wherein: said stimulant laxative isincorporated in said solid food item.
 28. The kit according to claim 26wherein: said PEG laxative is incorporated in said drink mix.
 29. Thekit of claim 26 wherein said stimulant laxative is comprised of senna.30. The kit of claim 26 wherein said PEG laxative is PEG-3350.
 31. Thekit according to claim 26 wherein: said stimulant laxative and said PEGlaxative work in synergy.
 32. The kit according to claim 26 wherein saidthree pre-packaged meals are comprised of: said solid food item havingapproximately 0-64 mg of senna provided therewith; and said drink mixprovided with approximately 17-34 gm of PEG-3350.
 33. The kit accordingto claim 26 wherein said three pre-packaged meals are comprised of: saidsolid food having approximately 0-125 mg of senna provided therewith;and said drink mix provided with approximately 0-102 gm of PEG-3350. 34.The kit according to claim 26 wherein said three pre-packaged meals arecomprised of: said solid food having approximately 12.5-64 mg of sennaprovided therewith; and said drink mix provided with approximately 17-68gm of PEG-3350.
 35. The kit according to claim 26 wherein said threepre-packaged meals are comprised of: said solid food havingapproximately 37.5 mg of senna provided therewith; and said drink mixprovided with approximately 34 gm of PEG-3350.
 36. The kit according toclaim 21 wherein said stimulant laxative in the pre-packaged meal isincorporated into a solid food item selected from the group consistingof: muffin, oatmeal, pasta with sauce, beef or chicken based soup withcrackers.
 37. The kit according to claim 21 wherein the PEG-3350 in thedrink mix is incorporated in a drink mix selected from a groupcomprising: cran-apple drink mix, lemonade drink mix.
 38. The kitaccording to claim 26 wherein said pre-packaged snacks are comprised of:solid food items incorporating approximately 26-36 mg of senna; a drinkmix comprising approximately 68 gm of PEG-3350.
 39. The kit according toclaim 38 wherein said food item in the pre-packaged snacks incorporatesa solid food item selected from a group consisting of: chocolatepudding, chocolate bar, chocolate Rice Krispies treat.